Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
ConditionBurns
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSkingenix, Inc.
About this trial
To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults, 18 years of age or older on the day of signing the informed consent.
Thermal Burns not exceeding a total body surface area (TBSA) OF 25%, with at least one partial thickness burn of 0.5% TBSA or greater. If full thickness burn(s) are present at screening, the total full thickness burn area shall not exceed 10% TBSA. Note: TBSA excludes areas of superficial (first degree) burns.
Able and willing to give informed consent and comply with study procedures.
Disqualifiers
infected.
circumferential or deemed, in the judgment of the investigator, at high risk for developing compartment syndrome.
partial thickness that is likely, in the judgment of the Investigator, to require grafting within 72 hours, or other non-protocol intervention.
Severe inhalation injury or other significant non-burn trauma.
Trial design
Design model
Parallel
Treatments tested in this trial
Investigational Drug, MW-III
DrugTopical application, twice a day
Silvadene® Cream 1% [Silver Sulfadiazine]
DrugTopical application, twice a day
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Investigational Drug, MW-IIIExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
Time frame
28 days Treatment PeriodSecondary outcomes
1
Proportion of subjects with partial thickness burns that are healed at each scheduled study assessment.
Proportion of subjects with partial thickness burns that are healed at each scheduled study assessment.
Time frame
28 days Treatment Period2
Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.
Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.
Time frame
28 days Treatment Period3
Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.
Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.
Time frame
28 days Treatment PeriodSponsors and contacts
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Source ClinicalTrials.gov